"We are of course very happy that the last patient has now been recruited regarding ALZ-101 in the high-dose part (part A2) of our phase 1b study. The recruitment has continued in an excellent way and the last patient has even been recruited earlier than we initially expected. As previously communicated, the results from the first part of the study showed a promising safety profile and an immune response in the patients who received ALZ-101. Through the high-dose part, which is now being carried out, we will evaluate the safety and tolerability of a higher dose of ALZ-101, which is important for the upcoming phase 2 study", comments Kristina Torfgård, CEO of Alzinova AB.

The complete analysis from the first part of the phase 1b study (Part A) reported in early 2024 confirmed the favorable safety and tolerability profile of the vaccine candidate ALZ-101. In addition, a high rate of immune response was demonstrated, and patients treated with ALZ-101 responded with antibody levels that increased with the number of doses given. The analysis also showed that the patients dosed with the highest dose of the vaccine responded to the treatment to a greater extent. In light of the good results, Alzinova applied to make an addition to the study where a further higher dose is evaluated. This reinforces Alzinova's knowledge of, among other things, dosing of ALZ-101, which optimizes the conditions for an upcoming clinical phase 2 study.

Now the last patient has been recruited in the high-dose part. Each patient is treated with 400 μg of the vaccine candidate ALZ-101. The high-dose part is done as an open-label part of the study and includes a total of six patients who will be treated on four occasions over a 16-week period. The patients will then be followed up for a further four weeks.

About Alzheimer's disease and the vaccine candidate ALZ-101
Alzheimer's is a fatal disease that initially affects the brain and leads to problems with memory, thinking and behavior. It is the most common form of dementia, and it usually affects older people. Symptoms develop gradually and include forgetfulness, confusion, and difficulty doing everyday things. The cause of the disease is not entirely clear, but the accumulation of harmful substances in the brain plays a role. There is currently no cure and although the first disease-modifying drugs have recently been approved in the United States, there is still a very long way to go to truly treat and prevent the progression of Alzheimer's disease.

Alzinova's approach, to develop vaccine and antibody treatments that specifically target the toxic accumulations of amyloid-beta in the form of oligomers in the brain, has several advantages over other approaches. Other treatments target larger accumulations of amyloid-beta, so-called plaques in the brain, which are believed to contain both harmful and harmless protein. Alzinova has developed a method that could specifically attack the harmful part in the brain, amyloid-beta oligomers, one of the underlying causes of Alzheimer's disease. Vaccination with ALZ-101 means that the body generates its own antibodies, specific against harmful accumulations of amyloid-beta oligomers in the brain. These harmful substances are expected to be neutralized, thus protecting the brain's synapses from damage that could slow or prevent the development of Alzheimer's disease. The treatment method is also expected to have a lower risk of side effects such as brain edema. The company therefore believes that it is likely to be more successful in contrast to other broader approaches to Alzheimer's disease.